Clinical trial · Interventional
Appropriate Timing of Surgery After Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer
Effect of Timing of Surgery After Neoadjuvant Chemoradiation on Histopathological Results, Complications, Recurrence and Survivals for Locally Advanced Rectal Cancer
NCT03287843CI-TRIAL-00057407completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aimed to compare the outcomes of early versus late surgical resection in patients who underwent curative total mesorectal excision after neoadjuvant chemoradiation. Half of the participants will undergo surgery before 8 weeks, while the other half will undergo surgery after 8 weeks.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasm, Rectum | Neoplasm | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Total mesorectal excision after 56 days (8-12 weeks) | Procedure | — | UNRESOLVED |
| Total mesorectal excision before 56 days (4-8 weeks) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Early surgery group
- description
- İn this arm patients will go under surgery before eight weeks, after neoadjuvant chemoradiation therapy.
- interventionNames
- Procedure: Total mesorectal excision before 56 days (4-8 weeks)
- type
- EXPERIMENTAL
- label
- Late surgery group
- description
- İn this arm patients will go under surgery after eight weeks, after neoadjuvant chemoradiation therapy.
- interventionNames
- Procedure: Total mesorectal excision after 56 days (8-12 weeks)
Primary outcomes (1)
- measure
- Pathological Complete Response Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Clinic stage II-III cancer ( T3- T4 tm or/and N(+) disease ) 2. Patients with histologically confirmed adenocarcinoma of the rectum 3. Tumor distal border located within 15 cm. from anal verge (as measured by rigid rectoscopy) 4. Standardized total mesorectal excision surgery 5. Tumor must be clinically resectable with curative intent (R0 resection must be most likely) 6. Elective operation 7. The patient must consent to be in the study and the informed consent must be signed Exclusion Criteria: 1. Clinic stage I and IV cancer disease 2. Patients with malignant disease of the rectum other than adenocarcinoma 3. Recurrent rectal cancer 4. Emergency cases (Mechanical bowel obstruction, perforation) 5. Other previous or concurrent malignancies 6. Any contraindication for radiochemotherapy 7. Previous chemotherapy or radiotherapy to the pelvis 8. Tumor has arisen from chronic inflammatory bowel disease or hereditary polyposis disease 9. American Society of Anesthesiologists Score \>3 patients
References
Publications (2)
- DERIVEDAkgun E, Caliskan C, Bozbiyik O, Yoldas T, Doganavsargil B, Ozkok S, Kose T, Karabulut B, Elmas N, Ozutemiz O. Effect of interval between neoadjuvant chemoradiotherapy and surgery on disease recurrence and survival in rectal cancer: long-term results of a randomized clinical trial. BJS Open. 2022 Sep 2;6(5):zrac107. doi: 10.1093/bjsopen/zrac107. PMID 36254732
- DERIVEDAkgun E, Caliskan C, Bozbiyik O, Yoldas T, Sezak M, Ozkok S, Kose T, Karabulut B, Harman M, Ozutemiz O. Randomized clinical trial of short or long interval between neoadjuvant chemoradiotherapy and surgery for rectal cancer. Br J Surg. 2018 Oct;105(11):1417-1425. doi: 10.1002/bjs.10984. Epub 2018 Aug 29. PMID 30155949